Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 104547 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10913] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by January 22, 2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare Part C 

Utilization Management Annual Data 

Submission and Audit Protocol Data 

Request; Use: Section 1857(d) of the 

Act, added by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 and implementing 

regulations at 42 CFR 422.503 and 

422.504 state that CMS must oversee an 

MA organization’s continued 

compliance with the requirements for a 

MA organization. Additionally, per 

§ 422.516(a), MA organizations are 

required to compile and report to CMS 

information related to the utilization of 

services, and other matters as CMS may 

require. 

The information gathered during this 

annual data collection and audit will be 

used by the Medicare Parts C and D 

Oversight and Enforcement Group 

(MOEG) within the Center for Medicare 

(CM) to assess Sponsoring 

organizations’ compliance with 

Medicare UM requirements. CMS will 

utilize the data submitted during the 

annual data submission to assess the 

number of items and services that have 

associated internal coverage criteria, 

and to develop a landscape of items and 

services across the nation to assess 

trends related to the development and 

utilization of internal coverage criteria. 

Additionally, CMS will use the annual 

submission to select a number of 

Sponsoring organizations to undergo 

UM audits each year, and to select 

specific items and services to audit. 

Annual UM data submissions, for all 

Sponsoring organizations, will be due to 

CMS by January 31 of each calendar 

year. Form Number: CMS–10913 (OMB 

control number: 0938–new); Frequency: 

Yearly; Affected Public: Private Sector, 

Business or other for-profits, Not-forprofits institutions; Number of 

Respondents: 179; Total Annual 

Responses: 179; Total Annual Hours: 

19,180. (For policy questions regarding 

this collection contact Caroline Zeman 

at 410–786–1564). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–30619 Filed 12–20–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–R–52] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

the necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions, 

the accuracy of the estimated burden, 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

February 21, 2025. 


khammond on DSK9W7S144PROD with NOTICES
104548 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number: lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–R–52 End Stage Renal Disease 

(ESRD) Conditions for Coverage and 

Supporting Regulations 

CMS–10901 Expanding Access to 

Women’s Health Grant 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collections 

1. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: End Stage Renal 

Disease (ESRD) Conditions for Coverage 

and Supporting Regulations; Use: The 

Centers for Medicare and Medicaid 

Services (CMS) is requesting 

reinstatement of OMB Control number 

0938–0386 (CMS–R–52) in compliance 

with the Paperwork Reduction Act 

(PRA). This package applies to existing 

Medicare End-stage Renal Disease 

(ESRD) conditions for coverage (CfCs) at 

42 CFR 494. Section 299I of the Social 

Security Amendments of 1972 (Pub. L. 

92–603) originally extended Medicare 

coverage to insured individuals, their 

spouses, and their dependent children 

with ESRD who require dialysis or 

transplantation. Subsequently, the ESRD 

Amendments of 1978 (Pub. L. 95–292) 

amended title XVIII of the Social 

Security Act (the Act) by adding section 

1881. Section 1881(b)(1) of the Act 

authorizes the Secretary to prescribe 

health and safety requirements (known 

as conditions for coverage) that a facility 

providing dialysis and transplantation 

services to patients must meet to qualify 

for Medicare reimbursement. Final 

regulations were published June 3, 

1976. Subsequent to the publication of 

the final regulations, the ESRD 

Amendments of 1978 were enacted to 

amend title XVIII of the Act to include 

section 1881(c). This section establishes 

ESRD network areas and Network 

organizations to assure the effective and 

efficient administration of ESRD 

program benefits. The requirements 

from section 1881(b) and (c) are 

implemented in regulations at 42 CFR 

part 405, subpart U, Conditions for 

Coverage for dialysis facilities. 

On April 7, 1986, the Consolidated 

Omnibus Budget Reconciliation Act of 

1975 (COBRA) (Pub. L. 99–272) was 

enacted which requires the Secretary to 

maintain renal disease Network 

organizations as authorized under 

section 1881(c) of the Act, and not 

merge the Network organizations into 

other organizations or entities. On April 

15, 1986, we published a notice of 

proposed rulemaking to implement 

section 9214 of Public Law 99–272. A 

final rule (HSQ–115) was published 

August 26, 1986 which included 

information collection requirements at 

§ 405.2112(e). This rule revised the 

requirements in regulations pertaining 

to the ESRD networks and organizations 

and establishes new, more efficient 

Network organizations. 

Revisions resulting from two 

additional rules: HSQ–137—ESRD: 

Responsibilities of Network 

Organizations, published January 21, 

1988; and BERC–434—Medicare 

Program: Standards for the Reuse of 

Hemodialyzer Filters and Other Dialysis 

Supplies, published October 2, 1987, are 

also included. HSQ–137–ESRD 

approved information collection 

requirements at §§ 405.2112(f) and (j). 

BERC–434 approved information 

collection requirements stemming from 

the following historical sections of the 

CFR including §§ 405.2136(b), 

405.2138(a), 405.2139(a), and 

405.2140(b) and (c). 

Major revisions to the CFR established 

new ESRD CfCs at 42 CFR 494 issued in 

a final rule, ‘‘Medicare and Medicaid 

Programs; Conditions for Coverage for 

End-Stage Renal Disease Facilities,’’ 

published on April 15, 2008 (CMS– 

3818–F). This rule modified, removed, 

added, and redesigned CfCs that dialysis 

facilities must meet to be certified under 

the Medicare program. This rule 

approved information collection 

requirements at §§ 494.30, 494.40, 

494.50, 494.60, 494.70, 494.80, 494.90, 

494.100, 494.110, 494.120, 494.150, 

494.170, and 494.180. 

An additional revision to the ESRD 

CfCs at 42 CFR 494 was precipitated by 

CMS–3818–F at 414.330(a)(2)(iii)(C). 

The burden to ESRD home dialysis 

suppliers associated with this 

requirement would be the time and 

effort necessary to collect all data for 

each patient receiving home dialysis 

care with respect to services and items 

furnished. However, the payment 

method that covered these suppliers 

was eliminated in 2011 and there are no 

longer any such entities. See 42 CFR 

parts 410, 413 and 414 Medicare 

Program; End-Stage Renal Disease 

Prospective Payment System; Final Rule 

and Proposed Rule at the following link 

Federal Register https://

www.govinfo.gov/content/pkg/FR-2010- 

08-12/pdf/2010-18466.pdf. 

Therefore, there are no actual costs 

associated with this requirement; we 

removed it from this package. 

An additional revision to the ESRD 

CfCs at 42 CFR part 494 was 

precipitated by interim final rule, 

‘‘Medicare Program; Conditions for 

Coverage for End-Stage Renal Disease 

Facilities-Third Party Payment,’’ 

published on December 14, 2016 (CMS– 

3337–IFC). This rule established new 

requirements for Medicare-certified 

dialysis facilities that make payments of 

premiums for individual market health 

plans. This interim final rule 


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Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 104549 

established additional burden 

associated with §§ 494.70(c) and 

494.180(k); these were quantified in the 

preceding information collection which 

expired in 2024 (OMB Control Number 

0938–0386). Since these regulations 

were not finalized due to litigation, they 

are no longer in effect. Therefore, we 

took out these sections from this 

package as they do not impose any 

burden. 

An additional revision to the ESRD 

CfCs at 42 CFR 494 was precipitated by 

final rule, ‘‘Medicare and Medicaid 

Programs; Emergency Preparedness 

Requirements for Medicare and 

Medicaid Participating Providers and 

Suppliers,’’ published September 16, 

2016 (CMS–3178–F). This rule 

established the creation and 

maintenance of an Emergency 

Preparedness Plan at 494.62(a), an 

Emergency Preparedness Policies and 

Procedures document at 494.62(b), an 

Emergency Preparedness 

Communication Plan at 494.62(c), a 

training program 494.62(d), and 

documentation of training exercises 

494.62(e). These information collections 

are in separate package, OMB Control 

number 0938–1325. 

On July 5, 2024, revisions to the CfC 

were proposed in ‘‘Medicare Program; 

End-Stage Renal Disease Prospective 

Payment System, Payment for Renal 

Dialysis Services Furnished to 

Individuals with Acute Kidney Injury, 

Conditions for Coverage for End-Stage 

Renal Disease Facilities, End-Stage 

Renal Disease Quality Incentive 

Program, and End-Stage Renal Disease 

Treatment Choices Model’’, (CMS– 

1805–P). This rule proposed to expand 

coverage of home dialysis services to 

patients with acute kidney injury (AKI). 

Since the ESRD CfCs apply to dialysis 

facilities, not to people with ESRD, this 

rule proposes to revise language in the 

CfCs to allow beneficiaries with AKI to 

utilize home dialysis. Specifically, we 

refer to facilities abiding by the ESRD 

CfCs as ‘dialysis facilities’ opposed to 

‘ESRD facilities and all patients seeking 

services from dialysis facilities as 

‘patients’ rather than ‘ESRD patients.’ 

There is no ICR burden associated with 

these changes however we made 

confirming changes to the language in 

this package. 

The CfCs are used by Federal (CMS), 

State surveyors (employed by State 

survey agencies), or CMS authorized 

accrediting organizations as a basis for 

determining whether a dialysis facility 

qualifies for approval or re-approval 

under Medicare. Surveyors make an inperson visit to the dialysis facility to 

perform the complete survey. 

The preceding information collection, 

which expired on March 31, 2024, 

estimated the total annual hourly 

burden as 1,260,491 hours at a cost of 

$64,839,657. We revise this to 800,621 

hours at a cost of $49,638,502. The 

reduction in hours and cost is largely 

due to removing the burden estimates 

that no longer apply. Form Number: 

CMS–R–52 (OMB Control Number: 

0938–0386); Frequency: Annually; 

Affected Public: Private sector— 

Business or other for-profit; Number of 

Respondents: 8,048; Total Annual 

Responses: 215,591; Total Annual 

Hours: 800,621 (For policy questions 

regarding this collection contact Claudia 

Molinar at 410–786–8445.) 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

information Collection: Expanding 

Access to Women’s Health Grant; Use: 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (PPACA), and 

on March 30, 2010, the Health Care and 

Education Reconciliation Act of 2010 

was also signed into law (collectively 

referred to as the ‘‘ACA’’). The ACA 

includes a number of provisions that 

reform the health insurance markets and 

provide Federal consumer protections 

through amendments to title XXVII of 

the Public Health Service Act (PHS Act) 

and corresponding amendments to the 

Employee Retirement Income Security 

Act and the Internal Revenue Code. The 

ACA also includes significant grant 

funding for States to work with the 

Federal Government to implement the 

Federal market reforms and consumer 

protections. 

Section 1003 of the ACA adds a new 

section 2794 to the PHS Act entitled, 

‘‘Ensuring That Consumers Get Value 

for Their Dollars.’’ Specifically, section 

2794(a) requires the Secretary of the 

Department of Health and Human 

Services (the Secretary) (HHS), in 

conjunction with the States, to establish 

a process for the annual review of health 

insurance premiums to protect 

consumers from unreasonable rate 

increases. Section 2794(c) directs the 

Secretary to carry out a program to 

award grants to States. The data 

collection (quarterly and final reports) 

are a source of information on the 

State’s progress with meeting CMS 

expectations for the Expanding Access 

to Women’s Health Grant. The reports 

describe significant advancements 

towards the State’s goal of enhancing 

and expanding access to reproductive 

and maternal health coverage and 

services from the beginning of the grant 

period through the completion of the 

grant period. The data collection is 

imperative to CMS being able to assess 

the State’s progress, barriers, and 

updates on measurable objectives. 

Without the data collection, CMS will 

be unable to efficiently monitor the 

State’s progress. It will also inhibit 

CMS’ ability to support and share 

opportunities of best practices with 

other States. Form Number: CMS–10901 

(OMB control number 0938–NEW); 

Frequency: Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 15; Total 

Annual Responses: 68; Total Annual 

Hours: 840. (For policy questions 

regarding this collection contact Jim 

Taing at James.Taing@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–30502 Filed 12–20–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Center for Drug 

Evaluation and Research (CDER), Office 

of Medical Policy (OMP) has modified 

their organizational structure. The new 

organizational structure was approved 

by the Secretary of Health and Human 

Services on November 19, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Wade, Acting Director, Division 

of Reorganizations and Delegations of 

Authority, Office of Budget, Office of 

Finance, Budget, and Acquisitions, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 240–731–0192. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect the FDA’s 

reorganization of the CDER, OMP. 


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